A Study to Evaluate Safety and Efficacy of Caelyx in Combination With Cyclophosphamide in the Treatment of Metastatic Breast Cancer (P02948)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. The aim of this study is to evaluate the safety and efficacy of Caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.

Caelyx 35 mg/m2 intravenously, on Day 1, every 3 weeks, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.

Other Name: SCH 200746

Drug: Cyclophosphamide

Cyclophosphamide 600 mg/m2, intravenously, on Day 1, every 6 weeks, during 6 cycles (concomitantly with Caelyx). Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.

Time to response; Duration of response; Time to progression; Survival [ Time Frame: With complete or partial response, subjects will be re-evaluated 4 weeks later to confirm the initial observation; Follow-up for a minimum of one year for survival. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.